3.1
NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 10 sources, which was discussed by the committee. The evidence included 3 systematic reviews and meta-analyses, 1 randomised controlled trial, 3 non-randomised comparative studies, 2 case series, and a review of the MAUDE database and the Ethicon complaint database. It is presented in the summary of key evidence section in the overview.